HeadliceNCT07391059
Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lice Infestation
A study testing COMPARATOR DEVICE, Pouxit ® in people with Headlice, run by Perrigo CSCI at 1 site in Mauritius.
Trial summary
Pediculosis capitis or head lice infestation is a human medical condition caused by the infestation of the hair by the parasitic insect Pediculus humanus capitis (human head lice). Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Headlice
- What is being tested?
- COMPARATOR DEVICE, Pouxit ®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteMauritius
- Study dates
- Feb 2026to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Healthy participant,
- Female or male participants,
- Aged 2 years and above (for participants in arms 1 and 2),
- Aged 3 years and above (for participants in arms 3) ,
- Participants with a slight to moderate lice infestation (According to EU norms: 0, 1, 2)
- Participants with various hair types (from 1 to 3C in the hair scale below) and hair length (from short to mid length hair not exceeding shoulder).
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- Written informed consent for participants ≥18 years or legal guardian for participants <18 years given freely and expressly before start of the clinical investigation.
- Participant/Participant's legal guardian is psychologically able to understand the clinical investigation related information and to give written informed consent.
- Participant/participant's legal guardian agreeing to follow the study requirements during the whole clinical investigation period.
- Females of childbearing potential and sexually active should use a contraceptive regimen recognized as effective at least 4 weeks before the beginning of the clinical investigation and during the entire clinical investigation.
- Female participants of childbearing potential, presenting with negative pregnancy test at inclusion.
Who cannot join
- Pregnant or nursing woman or planning a pregnancy during the clinical investigation;
- Participant who had been deprived of their freedom by an administrative or legal decision or major participant who is under guardianship;
- Participant in a social or sanitary establishment;
- Participant being in an exclusion period from a previous clinical investigation or who is currently participating to another clinical investigation on hair/scalp or who participated to another clinical clinical investigation on hair/scalp within 3 months before first visit.
- Participant suspected to be non-compliant according to the Investigator's judgment.
- Participant allergic to any of the ingredients and/or materials of the intended to be used products (investigation device and anti-lice comb, comparative device, post-treatment shampoo).
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- Participant with curly hair (from 4A to 4C in the hair type scale).
- Participant with hair length exceeding shoulder.
- Participants with more than 24 lice on the head.
- Participant suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the clinical investigation results.
- Participant with a cutaneous disease on the studied zone (scalp and hair).
- Severe scratches or open wounds/skin damage on the scalp (lice bites allowed however).
- Participant with a known or suspected allergy to one or more of the components of the investigational or comparator devices.
- Participant who has diabetes.
- Participant with known or suspected immune deficiency or autoimmune disease.
- Participant undergoing a topical treatment on the test area or a systemic treatment with:
- anti-inflammatory medication and/or anti-histamines during the previous 2 weeks and during the clinical investigation;
- corticosteroids during the 2 previous weeks and during the clinical investigation;
- retinoids and/or immunosuppressors during the 3 previous months and during the clinical investigation ;
- any medication stabilized for less than one month.
- Participant who received an anti-lice treatment in the previous month.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mauritius1 site
CIDP
Phoenix, 73408
Nanda MUNGUR, (230) 401 2600, n.mungur@cidp-cro.com
Gitanjali PETKAR, Dermatologist
About this study
Official title: Randomized Medical Device Class IIa Clinical Investigation to Assess the Safety and Efficacy of a New Shampoo for Head Lice Treatment
Pediculosis capitis or head lice infestation is a human medical condition caused by the infestation of the hair by the parasitic insect Pediculus humanus capitis (human head lice). The most common symptom of infestation is pruritus (itching) on the head which normally intensifies 3 to 4 weeks after the initial infestation.
The test item has been developed with the ambition to offer a complete head lice treatment, whilst also offering ultimate convenience in use - making treatment of head lice infestation easy, and effective in few minutes.
The objectives of this clinical study are to assess the efficacy and the safety of a new Medical Device shampoo for lice infestation treatment compared to a comparator device, already in market.
- Conditions
- Headlice
- Being tested
- INVESTIGATIONAL DEVICE, Paranix ® shampoo 2 minutes, INVESTIGATIONAL DEVICE, Paranix ® shampoo 5 minutes, COMPARATOR DEVICE, Pouxit ®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVESTIGATIONAL DEVICE, Paranix ® shampoo 2 minutesOther
New medical device shampoo for the treatment of head lice infestation: Paranix ® with 2 minute application time
INVESTIGATIONAL DEVICE, Paranix ® shampoo 5 minutesOther
New medical device shampoo for the treatment of head lice infestation: Paranix ®, with 5 minutes application time
COMPARATOR DEVICE, Pouxit ®Other
well established medical device shampoo for the treatment of head lice infestation - Pouxit ®
| Study group | Role | What they receive |
|---|---|---|
| INVESTIGATIONAL DEVICE Paranix ® shampoo , 2 MINUTES | Experimental | New medical device shampoo for the treatment of head lice infestation, 2 min treatment time : Paranix ® Receives: Other: INVESTIGATIONAL DEVICE, Paranix ® shampoo 2 minutes |
| INVESTIGATIONAL DEVICE Paranix ® shampoo, 5 MINUTES | Experimental | New medical device shampoo for the treatment of head lice infestation, 5 min treatment time : Paranix ® Receives: Other: INVESTIGATIONAL DEVICE, Paranix ® shampoo 5 minutes |
| COMPARATOR DEVICE, Pouxit ® shampoo | Active comparator | Head lice shampoo treatment (medical device class 1) already in market in europe: Pouxit ® Receives: Other: COMPARATOR DEVICE, Pouxit ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure Rate after complete treatment
The cure rate is defined as the rate of subjects having no live lice on scalp 7 days after the last application of the product.
Measured: 7 days
Cure Rate after complete treatment
The cure rate is defined as the rate of subjects having no live lice on scalp 7 days after the last application of the product.
Measured: 14 days
Secondary outcomes (5)
Cure rate after one dose of Investigational device (ID)
Comparison of the percentage of participants cured after one dose of the investigational device at 2 minutes compared to the percentage of participants cured with the investigational device at 5 minutes ( after one dose) , compared to the percentage of participants cured with one dose and two doses of the comparator device.
Measured: Day 7
Number of dead and live lice/nymphs after treatment
Assessment of the effect of the investigational shampoo on head lice infestation, measured by the number of dead and live lice/nymphs, and the presence of live or unbroken nits collected randomly from the anti-lice comb after treatment. Counting will be done visually using dermatoscope.
Measured: Day 0 and Day 7 if applicable
Number of live lice and nymphs, after application of treatment
Assessment of the effect of the investigational shampoo on head lice infestation, measured by the number of dead and live lice/nymphs, and the presence of live or unbroken nits collected randomly from the anti-lice comb one day after treatment. Counting will be done visually using dermatoscope.
Measured: Day 1 and Day 8 if applicable
Number of participants with treatment-related adverse events as assessed by investigator
Evaluation of the safety and tolerability of the investigational device versus comparator
Measured: Day 0, Day 1, Day 7, Day 8 and Day 14 if applicable
Subject reported perceived acceptability, effectiveness and subjective evaluation assessed via questionnaire data
Evaluation of the perceived acceptability, effectiveness and subjective evaluation. Subject perception questionnaire with:
- A questionnaire at day 1 consisting of 16 questions with a 4-levels scale (strongly disagree , disagree, agree, strongly agree) and 2 questions with a binary scale (yes, no).
- A questionnaire at end of study (day 7 or day 14) consisting of 9 questions with a 4-levels scale (strongly disagree , disagree, agree, strongly agree) and 4 questions with a binary scale (yes, no).
Measured: Day 1 , Day 7 or Day 14 if applicable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadliceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perrigo CSCI
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gitanjali PETKAR, Dermatologist, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391059
- Sponsor's protocol ID
- 2425CMPH047
- Status last verified
- Jan 2026
- First submitted
- 18 Sep 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Medical Device Class IIa Clinical Investigation to Assess the Safety and Efficacy of a New Shampoo for Head Lice Treatment
- ClinicalTrials.gov ID
- NCT07391059
- Acronym / sponsor ID
- 2425CMPH047
- Conditions
- Headlice
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Perrigo CSCIIndustry (pharma, biotech, devices)
- Study start
- Feb 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pediculosis capitis or head lice infestation is a human medical condition caused by the infestation of the hair by the parasitic insect Pediculus humanus capitis (human head lice). The most common symptom of infestation is pruritus (itching) on the head which normally intensifies 3 to 4 weeks after the initial infestation.
The test item has been developed with the ambition to offer a complete head lice treatment, whilst also offering ultimate convenience in use - making treatment of head lice infestation easy, and effective in few minutes.
The objectives of this clinical study are to assess the efficacy and the safety of a new Medical Device shampoo for lice infestation treatment compared to a comparator device, already in market.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| INVESTIGATIONAL DEVICE Paranix ® shampoo , 2 MINUTES | Experimental | Other: INVESTIGATIONAL DEVICE, Paranix ® shampoo 2 minutesNew medical device shampoo for the treatment of head lice infestation, 2 min treatment time : Paranix ® |
| INVESTIGATIONAL DEVICE Paranix ® shampoo, 5 MINUTES | Experimental | Other: INVESTIGATIONAL DEVICE, Paranix ® shampoo 5 minutesNew medical device shampoo for the treatment of head lice infestation, 5 min treatment time : Paranix ® |
| COMPARATOR DEVICE, Pouxit ® shampoo | Active comparator | Other: COMPARATOR DEVICE, Pouxit ®Head lice shampoo treatment (medical device class 1) already in market in europe: Pouxit ® |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy participant,
- Female or male participants,
- Aged 2 years and above (for participants in arms 1 and 2),
- Aged 3 years and above (for participants in arms 3) ,
- Participants with a slight to moderate lice infestation (According to EU norms: 0, 1, 2)
Key exclusion criteria (21 listed)
- Pregnant or nursing woman or planning a pregnancy during the clinical investigation;
- Participant who had been deprived of their freedom by an administrative or legal decision or major participant who is under guardianship;
- Participant in a social or sanitary establishment;
- Participant being in an exclusion period from a previous clinical investigation or who is currently participating to another clinical investigation on hair/scalp or who participated to another clinical clinical investigation on hair/scalp within 3 months before first visit.
- Participant suspected to be non-compliant according to the Investigator's judgment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INVESTIGATIONAL DEVICE, Paranix ® shampoo 2 minutesNew medical device shampoo for the treatment of head lice infestation: Paranix ® with 2 minute application time | Other | INVESTIGATIONAL DEVICE Paranix ® shampoo , 2 MINUTES |
| INVESTIGATIONAL DEVICE, Paranix ® shampoo 5 minutesNew medical device shampoo for the treatment of head lice infestation: Paranix ®, with 5 minutes application time | Other | INVESTIGATIONAL DEVICE Paranix ® shampoo, 5 MINUTES |
| COMPARATOR DEVICE, Pouxit ®well established medical device shampoo for the treatment of head lice infestation - Pouxit ® | Other | COMPARATOR DEVICE, Pouxit ® shampoo |
Primary outcome
Cure Rate after complete treatment
Time frame: 7 days
The cure rate is defined as the rate of subjects having no live lice on scalp 7 days after the last application of the product.
Cure Rate after complete treatment
Time frame: 14 days
The cure rate is defined as the rate of subjects having no live lice on scalp 7 days after the last application of the product.
5 secondary outcomes
Cure rate after one dose of Investigational device (ID)
Time frame: Day 7
Number of dead and live lice/nymphs after treatment
Time frame: Day 0 and Day 7 if applicable
Number of live lice and nymphs, after application of treatment
Time frame: Day 1 and Day 8 if applicable
Number of participants with treatment-related adverse events as assessed by investigator
Time frame: Day 0, Day 1, Day 7, Day 8 and Day 14 if applicable
Subject reported perceived acceptability, effectiveness and subjective evaluation assessed via questionnaire data
Time frame: Day 1 , Day 7 or Day 14 if applicable
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gitanjali PETKAR, Dermatologist principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COMPARATOR DEVICE, Pouxit ® in people with Headlice, run by Perrigo CSCI at 1 site in Mauritius.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mauritius. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nanda MUNGUR (+(230) 401 2600, n.mungur@cidp-cro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure Rate after complete treatment (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.